CN1785246A - Compounding injection prepn. contg. extractives of red-rooted salvia and total notogisennoside and its prepn. method - Google Patents
Compounding injection prepn. contg. extractives of red-rooted salvia and total notogisennoside and its prepn. method Download PDFInfo
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- CN1785246A CN1785246A CN 200410066167 CN200410066167A CN1785246A CN 1785246 A CN1785246 A CN 1785246A CN 200410066167 CN200410066167 CN 200410066167 CN 200410066167 A CN200410066167 A CN 200410066167A CN 1785246 A CN1785246 A CN 1785246A
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Abstract
A Chinese medicine in the form of injection for treating cerebral infarction, cerebral ischemia, coronary heart disease, angina pectoris, myocardiac infarction, etc is prepared from the extract of red sage root (50-80%) and arasaponin (20-50%).
Description
Technical field
The present invention relates to a kind of compound injection of forming by a certain percentage by salviamiltiorrhizabung extract and Radix Notoginseng total arasaponins and preparation method thereof.Belong to medical technical field.
Background technology
Cardiovascular and cerebrovascular disease is first killer of harm humans life and health, according to updated statistics, the whole world had 1,700 ten thousand people to die from cardiovascular disease in 2000, account for 1/3 of the total death toll of global a variety of causes, expect this numeral of the year two thousand twenty and will increase to 2,500 ten thousand, and wherein 80% all in developing country.
According to China's population analysis on cause of death in 1997, tumor held pride of place in the urban population cause of death, and cerebrovascular accounts for second, and both numerical value is bordering on equal; Respiratory system disease holds pride of place in the rural population cause of death, and cerebrovascular accounts for second.Ischemic cerebrovascular is all accounting for 70% in the cerebrovascular.Cardiovascular and cerebrovascular disease has quite high sickness rate and disability rate, can not be ignored.
Radix Notoginseng is traditional simply dissipating blood stasis hemostasis, the Chinese medicine of subduing swelling and relieving pain.A large amount of studies show that Radix Notoginseng is comparatively obvious to the cardiovascular effect, and its effective site is Radix Notoginseng total arasaponins.Clinically, Radix Notoginseng total arasaponins intravenously administrable (XUESAITONG injection and XUESHUANTONG ZHUSHEYE) is being widely applied, owing to be pure Radix Notoginseng total arasaponins administration, the saponin dosage is bigger, also is prone to untoward reaction such as saponin haemolysis clinically.
Radix Salviae Miltiorrhizae is the dry root and rhizome of labiate Radix Salviae Miltiorrhizae.Radix Salviae Miltiorrhizae can blood circulation promoting, coronary artery dilator, and blood flow increasing prevents that platelet from condensing effects such as protection myocardial ischemia.Pharmacology aspect (the extract Tan of Radix Salviae Miltiorrhizae) has study of anti-atherogenic effect, dwindles myocardial infarction area, reduces myocardial oxygen consumption, anti-inflammation, antitumor action, natural anti-oxidation etc.Be commonly used to treat diseases such as coronary heart disease, angina pectoris, cerebral infarction clinically.
Compound preparation with Radix Salviae Miltiorrhizae extract and Radix Notoginseng total arasaponins compatibility yet there are no separately, pertinent literature is not reported yet, both have definite curative effect to the cardiovascular and cerebrovascular vessel acute illness, can bring into play synergism behind the compound recipe, cardiovascular and cerebrovascular vessel acute attack stage particularly, onset and reach therapeutic purposes rapidly.
Summary of the invention
The object of the present invention is to provide a kind of compound injection of the treatment cardiovascular and cerebrovascular disease of making by raw material of Chinese medicine recurrence due to taking drug side compatibility.
Another object of the present invention is to provide the preparation method of this compound injection.
The compound injection of treatment cardiovascular and cerebrovascular disease of the present invention is aided with conventional pharmaceutic adjuvant by following raw materials by weight percent medicine and is prepared from by common process: Radix Salviae Miltiorrhizae extract 50-80%, Radix Notoginseng total arasaponins 20-50%.
Above-mentioned Radix Salviae Miltiorrhizae extract is the extract of commercially available Chinese crude drug; Above-mentioned Radix Notoginseng total arasaponins is commercially available medicinal raw material, contains the ginsenoside Rg
1, Rb
1, Panax Notoginseng saponin R
1Deng, the content of total saponins can be 50-90%.
Radix Salviae Miltiorrhizae extract has pharmacological action widely and good clinical therapeutic efficacy, clinical practice safe dose wide ranges, no obvious toxic-side effects, untoward reaction is few, incidence rate is low, though the single targeting intensity of Radix Salviae Miltiorrhizae extract is not as chemical synthetic drug, but the effect link of Radix Salviae Miltiorrhizae extract is many, toxic and side effects is few, aboundresources, advantage such as cheap becomes it to be used for the treatment of cardiovascular and cerebrovascular disease clinically, digestive system disease, the important drugs of diseases such as respiratory system, the important drugs that is widely used for preventing cardiovascular and cerebrovascular disease acute attack and cerebrovascular disease recurrence especially.
Radix Notoginseng total arasaponins and Radix Salviae Miltiorrhizae extract, both have the quick acting effect to the cardiovascular and cerebrovascular vessel acute illness, can bring into play synergism behind the compound recipe, cardiovascular and cerebrovascular vessel acute attack stage particularly, onset and reach desired therapeutic effect rapidly.The hemostasis of Radix Notoginseng dissipating blood stasis, subduing swelling and relieving pain; The Radix Salviae Miltiorrhizae stasis-dispelling and pain-killing, promoting blood circulation to restore menstrual flow, relieving restlessness clears away heart-fire.The compatibility of this compound injection uses, and major advantage is, Radix Notoginseng total arasaponins and the potentiation of Radix Salviae Miltiorrhizae extract compatibility, and this preparation is rapid-action, the curative effect height.
This compound injection is in order to various cardiovascular and cerebrovascular diseases such as treatment ischemic brain injury, angina pectoris, myocardial ischemia, cerebral infarction.This compound injection can be injection types such as liquid drugs injection, powder pin and transfusion.It can overcome the shortcoming that former oral formulations absorption difference is waited a moment.Pharmacodynamic experiment proves that the Chinese medicine of forming with effective site Radix Notoginseng total arasaponins and the Radix Salviae Miltiorrhizae extract of Radix Notoginseng is used for the qi depression to blood stasis cardiovascular and cerebrovascular disease, and is evident in efficacy.This compound injection agent medicine shows that through toxicological experiment toxicity is minimum, and through the side's of tearing open research, our two medicines lump together adapted, obviously strengthens with any not only drug effect wherein than single, and has Attenuation.
The preparation method of the compound injection of treatment cardiovascular and cerebrovascular disease of the present invention is made up of following steps:
One, get Radix Salviae Miltiorrhizae extract, add 5-20 and doubly measure water for injection and stir and to make dissolving fully, standby;
Two, get Radix Notoginseng total arasaponins and add 5-20 and doubly measure water for injection dissolving, the aqueous solution of above-mentioned Radix Salviae Miltiorrhizae extract is slowly added, stir, the osmotic pressure regulator that milliosmolarity such as adds to makes dissolving;
Three, be the ultrafilter membrane ultrafiltration of 10000～30000 molecular weight through flux, embedding becomes injection or transfusion, and sterilization promptly gets injection, infusion preparation.
Above-mentioned osmotic pressure regulator is one or more in mannitol, sodium chloride or the glucose.
The preparation method of the compound injection of treatment cardiovascular and cerebrovascular disease of the present invention is made up of following steps:
One, get Radix Salviae Miltiorrhizae extract, add 5-20 and doubly measure water for injection and stir and to make dissolving fully, standby;
Two, get Radix Notoginseng total arasaponins and add 5-20 and doubly measure water for injection dissolving, the aqueous solution of above-mentioned Radix Salviae Miltiorrhizae extract is slowly added, stir dissolving;
Three, the add-on type agent makes dissolving;
Four, with the proper amount of water for injection dilution, stir;
Five, the ultrafilter membrane ultrafiltration of via hole diameter 30000～100000 molecular weight, the ultrafiltrate packing, lyophilizing, gland promptly gets injectable powder.
Described forming agent is one or more in mannitol, HP-or the glucose.
Pharmacodynamics test of the present invention:
One, intraluminal middle cerebral artery occlusion in rats is caused the effect of cerebral ischaemia
Get 6 groups of male SD rats and be divided into sham operated rats, cerebral ischemic model group, nimodipine positive drug control group and injection group of the present invention, Radix Salviae Miltiorrhizae extract group, Radix Notoginseng total arasaponins group at random, every group of 10 animals.Cause cortex of cerebral hemispheres and the basal nuclei ischemia injury model of rat according to blocking-up rat medium-sized artery (MCAO) method.Each organizes intravenous injection once, and administration is after 30 minutes, and each Mus is with 10% chloral hydrate anesthesia (300mg/kg, ip), undergo surgery by literature method, postoperative 24 hours broken end is got brain, dyed after, take out respectively and be normal cerebral tissue rosy and be linen blocking tissue, weigh,, obtain the percentage ratio that the infarct area accounts for the hemisphere gross area then according to the weight area method, t method of inspection and model group are carried out significance test relatively between i.e. infraction rate, and employing group.The results are shown in Table 1:
The influence of the table 1 pair rat cerebral infarction scope (n=10 of X ± S)
| Group | Dosage (mg/kg) | Number of animals (n) | Infarct size/brain sections the gross area (%, X ± S) |
| Of the present invention group of Radix Salviae Miltiorrhizae extract group of sham operated rats model group Radix Notoginseng group nimodipine group | 30 15 15 2 | 10 10 10 10 10 10 | 0 20.69±8.06 ## 12.29±5.75 * 17.38±7.20 16.45±5.65 10.71±2.08 ** |
Annotate: compare with sham operated rats,
##P＜0.01; Compare with model group,
*P＜0.05,
*P＜0.01.
Result of the test is learned by statistics and is shown, model group has been compared significant difference with sham operated rats, shows rat MCAO modeling success.Compare with model group, injection group of the present invention can obviously reduce animal brain infraction rate, significant difference (P＜0.05) is arranged, and Radix Salviae Miltiorrhizae extract and Radix Notoginseng group fail obviously to reduce animal brain cerebral infarction rate (P＞0.05), show the superiority of Radix Salviae Miltiorrhizae extract and notoginseng thus.
Two, the influence of AICI rat brain index and brain water content is tested
Get 6 groups of Wistar rats, be divided into sham operated rats, cerebral ischemic model group, nimodipine positive drug control group and injection group of the present invention, Radix Salviae Miltiorrhizae extract group, Radix Notoginseng total arasaponins group at random, every group of 10 animals.Sham operated rats and cerebral ischemic model group normal saline are irritated stomach, and all the other are respectively organized the corresponding medicine that gives and irritate stomach, and be administered once every day, successive administration 7 days.1h after the last administration, except that sham operated rats, all the other each groups form anxious imperfection cerebral ischemic model all by literature method ligation rat bilateral common carotid arteries.
Get above-mentioned animal pattern, 10 of every treated animals, behind bilateral ligation 3h, break end, open cranium and get brain, weigh rapidly, calculate cerebral index (heavy * 100/ body weight of cerebral index=brain), then that brain is roasting to constant weight in 110 ℃ of baking boxs, calculate brain water content (brain water content=(cutaneous horn weight-brain stem is heavy)/cutaneous horn heavy * 100%).The results are shown in Table 2:
(the n=10 of X ± S) of the influence of brain water content, cerebral index after the table 2 pair cerebral ischemic reperfusion in rats
| Group | Dosage (mg/kg) | Brain water content (%) | Cerebral index |
| Of the present invention Zu of (1: 0.5 of the present invention Zu of (1: 1) of the present invention Zu of (1: 2) Salvia root P.E Zu pseudo-ginseng Zu Nimodipine Zu of sham-operation Zu model group | 30 30 30 15 15 2 | 76.40±0.85 79.71±1.02 ## 78.32±0.69 ** 77.48±0.72 ** 77.49±0.71 ** 79.25±0.83 79.16±0.98 78.08±1.05 ** | 0.46±0.13 0.79±0.14 # 0.56±0.047 ** 0.59±0.05 ** 0.57±0.049 ** 0.71±0.07 0.73±0.09 0.60±0.06 ** |
Annotate: compare with sham operated rats,
##P＜0.01; Compare with model group,
*P＜0.05,
*P＜0.01.
Experimental result shows that AICI model group cerebral index and brain water content and sham operated rats relatively have significant difference, and brain water content increases, and shows rat AICI model modeling success; (Radix Salviae Miltiorrhizae extract: Radix Notoginseng total arasaponins was respectively 1: 5 the injection group of the present invention of three kinds of different proportions of injection group of the present invention, 1: 10,1: 20) brain water content and cerebral index all form significant difference (P＜0.01) with model, and all be lower than Radix Salviae Miltiorrhizae extract and Radix Notoginseng group (P＜0.05), illustrate that Radix Salviae Miltiorrhizae extract and Radix Notoginseng compatibility have certain reasonability, Radix Salviae Miltiorrhizae extract helps to improve Radix Notoginseng total arasaponins and enters maincenter and play a role, thereby improved its permeability, increased curative effect cerebral ischemic model.
Three, to the improvement effect of rats with cerebral ischemia cerebral blood flow
Get 6 groups of Wistar rats, be divided into sham operated rats, cerebral ischemic model group, nimodipine positive drug control group and injection group of the present invention, Radix Salviae Miltiorrhizae extract group, Radix Notoginseng total arasaponins group at random, every group of 10 animals.Make it produce the back pressure that is equivalent to 15～20mmHg according to rat brain blood vessel perfusion method on the throne, the different injection of reuse pours into respectively and enters cerebral circulation and can produce different vasomotion reaction, just can depict the variation of pressure by pressure transducer.The results are shown in Table 3:
The table 3 pair rat brain blood flow influence (n=10 of X ± S)
| Group | Dosage (mg/kg) | Number of animals (n) | Pressure (mmHg) before the perfusion | Perfusion back pressure (mmHg) |
| Of the present invention group of Radix Salviae Miltiorrhizae extract group of model group Radix Notoginseng group nimodipine group | 30 15 15 2 | 10 10 10 10 10 | 16.7±0.6 16.8±0.5 17.0±0.46 16.9±0.52 17.1±0.53 | 16.7±0.6 ## 4.65±1.81 ** 13.69±2.1 * 12.18±3.7 * 6.36±1.9 ** |
Annotate: compare with sham operated rats,
##P＜0.01; Compare with model group,
*P＜0.05,
*P＜0.01.
Result of the test shows that model group and sham operated rats relatively have significant difference (P＜0.01), make rat produce certain back pressure, shows rat modeling success.Back pressure and model group that injection group of the present invention produces relatively have significant difference (P＜0.01), effect is better than the Radix Salviae Miltiorrhizae extract group or the Radix Notoginseng total arasaponins group (P＜0.05) of single, show that the present invention has than Radix Salviae Miltiorrhizae extract or the better vasodilator effect of Radix Notoginseng total arasaponins, increase the cerebral blood flow of test Mus, the better cerebral blood flow increasing amount of Radix Salviae Miltiorrhizae extract and Radix Notoginseng compatibility also has been described, has improved the rat cerebral ischemia effect.
The specific embodiment:
Embodiment 1: the preparation of injection
Get Radix Salviae Miltiorrhizae extract 200g, add 1000ml water for injection and make dissolving fully.Get Radix Notoginseng total arasaponins 200g and add the dissolving of 2-4L water for injection.The aqueous solution of Radix Salviae Miltiorrhizae extract is slowly added in the aqueous solution of Radix Notoginseng total arasaponins, and the limit edged stirs to clarify, and is diluted to 10L with water for injection.The medicinal liquid via hole diameter is the ultrafilter membrane ultrafiltration of 10000 molecular weight, embedding, and 10ml/ props up, and sterilization promptly gets injection.
Embodiment 2: the preparation of transfusion
Get Radix Salviae Miltiorrhizae extract 200g, fine ground, add the stirring of 2400ml water for injection and make dissolving fully.Get Radix Notoginseng total arasaponins 200g and add the dissolving of 2-4L water for injection.The aqueous solution of Radix Salviae Miltiorrhizae extract is slowly added in the aqueous solution of Radix Notoginseng total arasaponins, the limit edged stirs, and the osmotic pressure regulator of milliosmolarity such as adds to, and this isotonic agent is at least a in mannitol, sodium chloride or the glucose, and be diluted to 100L or 250L with water for injection, stir.The medicinal liquid via hole diameter is the ultrafilter membrane ultrafiltration of 30000 molecular weight, and it is an amount of to replenish water for injection, is distributed into 100ml or 250ml/ bottle, irritates lid, and sterilization promptly gets and infuses.
Embodiment 3: the preparation of lyophilized injectable powder
Get Radix Salviae Miltiorrhizae extract 200g, fine ground, add the dissolving of 40ml water for injection, standby.Get Radix Notoginseng total arasaponins raw material 200g, add an amount of water for injection dissolving.Radix Salviae Miltiorrhizae extract solution is slowly added in the aqueous solution of Radix Notoginseng total arasaponins, the limit edged stirs to clarify, and is diluted to 50L with water for injection, dissolving.Medicinal liquid is the ultrafilter membrane ultrafiltration of 10000 molecular weight through flux, packing, and every bottle of 5ml, lyophilizing, gland, label promptly gets the powder pin, totally 10000 bottles.
Claims (5)
1, a kind of compound injection of the treatment cardiovascular and cerebrovascular disease of being made up of Radix Salviae Miltiorrhizae extract and Radix Notoginseng total arasaponins is characterized in that being aided with conventional pharmaceutic adjuvant by following raw materials by weight percent medicine is prepared from by common process: Radix Salviae Miltiorrhizae extract 50-80%, Radix Notoginseng total arasaponins 20-50%.
2, a kind of preparation method of the compound injection according to the described treatment cardiovascular and cerebrovascular disease of claim 1 is characterized in that being made up of following steps:
One, get Radix Salviae Miltiorrhizae extract, add 5-20 and doubly measure water for injection and stir and to make dissolving fully, standby;
Two, get Radix Notoginseng total arasaponins and add 5-20 and doubly measure water for injection dissolving, the aqueous solution of above-mentioned Radix Salviae Miltiorrhizae extract is slowly added, stir, the osmotic pressure regulator that milliosmolarity such as adds to makes dissolving;
Three, be the ultrafilter membrane ultrafiltration of 10000～30000 molecular weight through flux, embedding becomes injection or transfusion, and sterilization promptly gets injection, infusion preparation.
3, according to the preparation method of the compound injection of the described treatment cardiovascular and cerebrovascular disease of claim 2, it is characterized in that described osmotic pressure regulator is one or more in mannitol, sodium chloride or the glucose.
4, a kind of preparation method of the compound injection according to the described treatment cardiovascular and cerebrovascular disease of claim 1 is characterized in that being made up of following steps:
One, get Radix Salviae Miltiorrhizae extract, add 5-20 and doubly measure water for injection and stir and to make dissolving fully, standby;
Two, get Radix Notoginseng total arasaponins and add 5-20 and doubly measure water for injection dissolving, the aqueous solution of above-mentioned Radix Salviae Miltiorrhizae extract is slowly added, stir dissolving;
Three, the add-on type agent makes dissolving;
Four, with the proper amount of water for injection dilution, stir;
Five, the ultrafilter membrane ultrafiltration of via hole diameter 30000～100000 molecular weight, the ultrafiltrate packing, lyophilizing, gland promptly gets injectable powder.
5, according to the preparation method of the compound injection of the described treatment cardiovascular and cerebrovascular disease of claim 4, it is characterized in that described forming agent is one or more in mannitol, sodium chloride, HP-or the glucose.
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|---|---|---|---|
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|---|---|---|---|
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101926848A (en) * | 2009-06-19 | 2010-12-29 | 天津药物研究院 | Medicinal composition for treating heart cerebrovascular diseases and preparation thereof |
| CN104027525A (en) * | 2013-03-06 | 2014-09-10 | 中国人民解放军军事医学科学院放射与辐射医学研究所 | Drug for treatment of ischemic heart disease, preparation method and application thereof |
-
2004
- 2004-12-10 CN CN 200410066167 patent/CN1785246A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101926848A (en) * | 2009-06-19 | 2010-12-29 | 天津药物研究院 | Medicinal composition for treating heart cerebrovascular diseases and preparation thereof |
| CN101926848B (en) * | 2009-06-19 | 2013-03-20 | 天津药物研究院 | Medicinal composition for treating heart cerebrovascular diseases and preparation thereof |
| CN104027525A (en) * | 2013-03-06 | 2014-09-10 | 中国人民解放军军事医学科学院放射与辐射医学研究所 | Drug for treatment of ischemic heart disease, preparation method and application thereof |
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